Shoulder Osteoarthritis Clinical Trial
Official title:
Sling vs No Sling After Reverse Total Shoulder Arthroplasty
This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure - Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy - Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis - Rotator cuff arthropathy - Glenohumeral arthritis - Patient is between 18-100 years old - Patient is English speaking Exclusion Criteria: - A history of ipsilateral shoulder arthroplasty - A history of shoulder septic arthritis - A history of a proximal humeral fracture - Chronic locked dislocation - Rheumatoid arthritis - Tumors - Axillary nerve damage - Non-functioning deltoid muscle - Glenoid vault deficiency precluding baseplate fixation - Infection and neuropathic joints - Known or suspected non-compliance, drug or alcohol abuse - Patients incapable of judgement or under tutelage - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. - The subject is related to investigator as family members, employees, or other dependent persons |
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who develop any kind of postoperative complication | Incidence of postoperative complications | Up to the first 2 years following surgery | |
Secondary | American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score | The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Total score ranges from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. | Up to the first 2 years following surgery | |
Secondary | Single Assessment Numeric Evaluation (SANE) score | The SANE is a single-question outcome measure that asks patients to rate their function (as it pertains to the area being treated) on a scale of 0 to 100, where a higher score indicates greater function. | Up to the first 2 years following surgery |
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